The present invention relates generally to drug dispensing devices and, more particularly, to a device that produces and dispenses a strip of cream laden gauze from the gauze and cream contained therein.
In the medical field, there are many uses for cream-laden gauze or other cream-laden non-woven permeable materials. These types of combination products are useful in the treatment of skin wounds or abrasions in humans or animals by wrapping the damaged area with a gauze bearing a medicated cream. For example, cream laden gauze wrap for such external use might contain an antibiotic or debridement agent, a hemostatic substance to stop bleeding or other medicinal agents which would be positioned on a wound and subsequently covered with a bandage or dry gauze wrap. Such gauze wraps are frequently used to treat or prevent infections or other adverse events at damaged areas occurring on the extremities, the neck, head, torso or other body locations. Such cream laden gauze products are also used to form packs or plugs of such a combination gauze-with-medicated cream product to create pressure to stop bleeding, promote healing, or prevent or treat infections, for example. The gauze packs are used to provide certain medical benefits by inserting them into the body cavities of the body of man or animals, or into injury-caused or surgically-caused crevices, holes or incisions such as broken bones, cranial trepining, anal fissures such as pylenonital cysts, various rectal surgical procedures such as hemorrhoidal repair, or for posterior nosebleeds, and vaginal surgical procedures such as hysterectomy, vaginal floor or wall repair or reconstruction, cystocele repair and other gynecological surgical procedures.
Approximately 650,000 hysterectomies are performed each year in the United States alone. This equates to approximately 8 out of 1,000 women per year. The rate is similar in Canada, but lower in Europe and Asia, where they are performed on about 3 in 1,000 per year. At the conclusion of many hysterectomies it is desirable to stop the blood-vessel rich vaginal wall from bleeding, and to promote new tissue growth. This is conventionally accomplished with a vaginal “gauze pack” inserted immediately post-surgery while the patient is still in the operating room. Vaginal gauze packs impregnated with estrogen cream are effective because they stop bleeding via direct pressure, and promote new tissue growth due to the properties of the estrogens in the cream. Normally the gauze pack remains in the patient overnight, and is removed the next morning. Gauze packs are also used in other intravaginal procedures, including bladder prolapse surgery, interuterine fibroid surgery, and pelvic floor reconstruction.
Vaginal gauze packs are typically prepared in the operating room by a nurse or aide. They will place approximately 15′ of 2″ gauze in a large basin, add the contents of a an approximately 45 g tube of cream, knead the cream into the gauze, then attempt to untangle the resulting roll of cream laden gauze and fold it neatly for placement into the vaginal canal by the doctor.
The conventional methods of preparing vaginal gauze packs and other extemporaneously-prepared gauze pack or strips have substantial drawbacks. For one, it is a messy procedure that requires cleanup afterwards. Also, it is time consuming for operating room personnel. Moreover, approximately 15-20% of the cream is wasted, which is substantial considering, for example, that one 45 g of PREMARIN® bears a wholesale cost of about $90. Most importantly, however, is that cream coverage to the gauze can be non-uniform, thereby potentially lessening the positive effects of the gauze pack.
Thus, there remains a need for a new and improved device for preparing cream laden gauze, and a method for using this device. Ideally this device would be economical with respect to manufacturing and delivery. It should be simple to use, thereby reducing the time and expense in the operating room. Ideally the device is operable by one person, and this one person is able, for example, to prepare a 15′ to 25′ strip of cream laden gauze in approximately 30 seconds. It should also be adjustable insofar as the operator can increase or decrease the amount of cream being deposited on the gauze. The device should be disposable in non-biohazard trash, thereby decreasing clean-up costs. It should be less wasteful of cream than conventional preparation methods. Finally, it should produce cream laden gauze with uniformly deposited cream.